GLAMARYL 2 TABLET

Country: South Africa

Language: English

Source: South African Health Products Regulatory Authority (SAHPRA)

Available from:

WINTHROP PHARMACEUTICALS (PTY) LTD

Dosage:

See ingredients

Pharmaceutical form:

TABLET

Composition:

EACH TABLET CONTAINS GLIMEPIRIDE 2,0 mg

Authorization status:

Canceled

Authorization date:

2004-09-10

Patient Information leaflet

Page 1 of 6
PATIENT INFORMATION LEAFLET
Read all of this leaflet carefully before you start taking AMARYL
tablets.

Keep this leaflet. You may need to read it again.

If you have any questions, ask your doctor or pharmacist.

AMARYL has been prescribed for you personally and you should not share
your
medicine with other people. It may harm them, even if their symptoms
are the same as
yours.
SCHEDULING STATUS:
S3
PROPRIETARY NAME AND DOSAGE FORM:
AMARYL 1 (tablets)
AMARYL 2 (tablets)
AMARYL 3 (tablets)
AMARYL 4 (tablets)
WHAT AMARYL CONTAINS:
The active ingredient in your AMARYL tablets is glimepiride.
Each tablet also contains lactose, magnesium stearate,
microcrystalline cellulose, polyvidone
25 000 and sodium starch glycolate. In addition the tablets contain
colouring agents. The 1 mg
tablets contain red ferric oxide; the 2 mg and 3 mg tablets contain
yellow ferric oxide; and the 2
mg and 4 mg contain indigo carmine aluminium lake.
Page 2 of 6
WHAT AMARYL IS USED FOR:
Amaryl is one of a group of medicines called oral hypoglycaemics,
which are used for the
treatment of diabetes in patients whose blood sugar levels are not
adequately controlled by diet
and exercise alone. Diabetes is a disease where the body does not
produce enough insulin to
control the level of blood sugar. Oral hypoglycaemics help control
blood sugar levels.
BEFORE TAKING AMARYL:
DO NOT TAKE AMARYL IF:

you are allergic to glimepiride, other medicines used to treat high
blood sugar levels or
any of the ingredients listed above.

you are pregnant or breastfeeding.

you have liver problems.

you have Type 1 insulin-dependant diabetes mellitus.
TAKE SPECIAL CARE WITH AMARYL:

Stressful situations (e.g. trauma, surgery and febrile infections) may
affect blood sugar
levels and your medication may need to be adjusted.

Amaryl must be used with caution in patients with kidney problems and
G6PD-
deficiency.

If your blood sugar level is not lowered (hyperglycaemia) sufficiently
with Amaryl, you
may experience increased ur

Summary of Product characteristics

Page 1 of 16
SCHEDULING STATUS: S3
PROPRIETARY NAME AND DOSAGE FORM:
AMARYL 1 (tablets)
AMARYL 2 (tablets)
AMARYL 3 (tablets)
AMARYL 4 (tablets)
COMPOSITION:
Per tablet:
Glimepiride 1 mg
Glimepiride 2 mg
Glimepiride 3 mg
Glimepiride 4 mg
Excipients:
Each tablet also contains lactose, magnesium stearate,
microcrystalline cellulose, polyvidone
25 000 and sodium starch glycolate. In addition the tablets contain
colouring agents. The 1
mg tablets contain red ferric oxide; the 2 mg and 3 mg tablets contain
yellow ferric oxide; and
the 2 mg and 4 mg tablets contain indigo carmine aluminium lake.
PHARMACOLOGICAL CLASSIFICATION:
A 21.2 Oral hypoglycaemics
PHARMACOLOGICAL ACTION:
Page 2 of 16
Glimepiride is a sulphonylurea. Glimepiride decreases blood glucose
concentrations mainly by
stimulating insulin release from pancreatic beta cells. This effect is
based predominantly on an
improved responsiveness of the pancreatic beta cells to the
physiological glucose stimulus.
Glimepiride also has extra pancreatic (insulin-sensitising and
insulin-mimetic) effects.
The effect of glimepiride is dose-dependent over the dose range of 1
to 6 mg. The
physiological response to acute physical exercise, i.e. reduction of
insulin secretion, is still
present with glimepiride.
There was no significant difference in effect regardless of whether
glimepiride was given 30
minutes or immediately before a meal.
The absolute bioavailability of glimepiride is complete. Food intake
has no relevant influence
on absorption. Maximum serum concentrations are reached approximately
2,5 hours after oral
intake and there is a linear relationship between dose and both
maximum concentrations and
area under the time/concentration curve.
Glimepiride has a high protein binding (> 99 %). Mean dominant serum
half-life, which is of
relevance for the serum concentrations under multiple-dose conditions,
is about 5 to 8 hours.
After single-dose radiolabelled glimepiride, 58 % of the radioactivity
was recovered in the urine,
and 35 % in the faeces. No unchanged substanc